General

What is the goal of the Your Private Biome Project?

The genital microbiome can play a major role in reproductive and sexual health, but it is one of the least studied microbiome areas. In this citizen science project, we hope to greatly expand our understanding of the genital microbiome in individuals of all age and races, as well as other factors, such as diet, exercise, and even sexual orientation. The goal is to use this knowledge to develop new solutions that could be used to prevent, diagnose, and treat microbiome-related conditions.

How will the study be conducted?

Individuals can participate in the project by visiting (www.yourprivatebiome.org) and ordering a kit, which range from single to multiple collection options, as well as partner versions. Once the kit is received in the mail, the participant can create an account on the website, fill out a mandatory consent, and activate the kit. From there, they can complete sampling and an accompanying questionnaire before returning the kit for analysis.

Has this kind of study been done before?

There have been other Citizen Science projects similar to Your Private Biome, where the general public can purchase microbiome kits and submit samples for analysis. An example of this type of project is the American Gut Project (now the Human Food Project).

Who is conducting the Your Private Biome Study?

The University of Maryland and George Washington University are working together as partners on this project. UMaryland is responsible for study design and implementation, while GWU is co-leading study design and the analysis of genital microbiome and related metadata.

In addition to participant donation, do you have other sources of funding for this project?

Other sources of funding include the American Microbiome Institute and GWU School of Public Health.

Why is the study important to conduct and how will citizen scientists be helping to achieve this public health goal?

Citizen scientists can help to greatly advance our understanding of the genital microbiome by participating in the study. It is not feasible to collect the type of comprehensive data and scale of participation Your Private Biome provides within traditional academic research projects; therefore, citizen scientists will play a critical role in advancing this particular human microbiome area forward.

Are there any risks associated with participating in this study?

The risks associated with participating in the study are minor - the probability & magnitude of harm or discomfort anticipated in the research are no greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations.

Privacy

What does the project do to protect participant privacy?

This study has been approved by the IRB at the University of Maryland, a peer-reviewed process to assess scientific basis and address any potential ethical concerns inherent in the project, while also ensuring sufficient protections are in place to protect the privacy of those who participate in the study.

Who will have access to participant sample(s)?

Only the primary research team will have access to sample(s). It is important to know that participant sample(s) will only be labeled by a unique study ID and never private information or names.

How will the data collected from this study be used?

The data from Your Private Biome will be used in 2 main ways. Firstly, to generate a confidential report to be returned to the study participants. Secondly, the de-identified questionnaire and microbiome data (i.e., only labeled by study ID) will be pooled into a central database and eventually made available to other researchers who could use the data to make new discoveries.

With partner kits, are the reports disseminated to both parties?

For kit options that allow individuals to enroll in the study with another individual, the results of each individual’s report will be private and only accessible to the designated participant.

Sampling and Report

What should be done once the kit is received?

Once the kit is received, individuals should use the Website to create an account. The kit comes with sampling instructions and supplies, and the participant will need to complete a consent form along with a questionnaire to accompany the sample(s) being submitted. Once the sample(s) are collected, the participant can ship the sample(s) and signed consent form using the included return label.

What type of partners can participate with the partner kit?

All types of partners, including family members, spouses, and others, can participate in the study.

How old does a participant have to be to use a kit?

This study is only available to individuals age 18 and older and each individual must consent for him or herself in the 2-step process, both online and written. Other eligibility criteria include the individual must reside in the United States and be able to understand English.

How long will it take to receive a personalized report?

Once the samples have been received, the results will be available in approximately 6 weeks, and it will be uploaded into the individual’s account. If the individual opts to be contacted for other studies, they will be included in a study cohort that the research team could reach out to in the future.

What information is included in the report?

The report will contain two main types of information: a) The composition of one’s genital microbiome (including changes over time for specific kits) and b) How one’s genital microbiome compare to others in the study.

Where can a participant find their report?

The report can be found within the secure account portal located at YourPrivateBiome.com.

Can the report be used to investigate or diagnose individual health problems?

No. The report that participants receive will be for personal knowledge and not for making diagnostic or treatment decisions. Participants should work with healthcare providers to diagnose and treat any health-related concerns.